| CTRI Number |
CTRI/2025/08/092567 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare the effect and safety of adding pioglitazone to standard treatment in patients with depression. |
|
Scientific Title of Study
|
A comparative study on efficacy and safety of pioglitazone as add on therapy with standard therapy in patients with depression - A randomized open labelled prospective study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Divakar A |
| Designation |
PG student |
| Affiliation |
Government Kilpauk Medical college |
| Address |
Department of Pharmacology, Government Kilpauk medical college, Chennai
Chennai
TAMIL NADU
600010
India |
| Phone |
8072344604 |
| Fax |
|
| Email |
divasathi7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aruna T |
| Designation |
Professor and Head of department |
| Affiliation |
Government Kilpauk Medical college |
| Address |
Department of Pharmacology, Government Kilpauk medical college, Chennai
Chennai
TAMIL NADU
600010
India |
| Phone |
9444276923 |
| Fax |
|
| Email |
arunabala511@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aruna T |
| Designation |
Professor and Head of department |
| Affiliation |
Government Kilpauk Medical college |
| Address |
Department of Pharmacology, Government Kilpauk medical college, Chennai
Chennai
TAMIL NADU
600010
India |
| Phone |
9444276923 |
| Fax |
|
| Email |
arunabala511@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Hospital Government Kilpauk Medical College |
| Address |
Government Kilpauk Medical College Hospital, Chennai - 10 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Divakar A |
Government Kilpauk medical college |
Department of Psychiatry, OP block, Government Kilpauk medical college, Chennai - 10
Chennai
TAMIL NADU |
8072344604
divasathi7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Kilpauk medical college Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard therapy |
Tablet Citalopram 10 mg OD |
| Intervention |
Tablet Pioglitazone |
Tablet Pioglitazone 15 mg OD for first 2 weeks then 15 mg BD for 10 weeks as an add on therapy to standard therapy(Citalopram 10 mg) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with mild to moderate depression diagnosed by DSM 5 criteria with Hamilton Depression score 10-17.Patients with unresolved symptoms of depression with standard dose of antidepressant |
|
| ExclusionCriteria |
| Details |
Patients with severe depression
Electroconvulsive therapy within 6 months
Patients with substance abuse
Pregnant and lactating mothers
Patients with liver disease, heart failure, renal impairment |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Hamilton depression scores in study group |
Baseline, 4 weeks, 8 weeks, 12 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any adverse drug event due to Tablet Pioglitazone and Tablet Citalopram |
At every visit patient will be assessed for any adverse drug reactions with additional 1 month follow up |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aimed to assess the safety and efficacy of Pioglitazone in management of depression as an add on therapy to standard therapy in comparison with standard therapy alone. This can pave the way for new promising drug in treating depression with minimal side effects. Patients with depression fulfilling the Inclusion criteria will be included in the study. On enrollment all participants will be assessed clinically by Hamilton depression rating scale and patients with mild to moderate depression of score 10-17 will be included. Baseline investigations including CBC, RFT, LFT, FBS, PPBS, Lipid profile done before start of the study. Participants will be randomized into two groups. Participants in control group will take standard therapy T.Citalopram 10 mg OD. Participants in study group will take pioglitazone as an add on therapy to standard therapy for 12 weeks. Participants will be assessed clinically using HAM-D score after 12 weeks. All ADRs will be noted, analyzed and reported to Regional Pharmacovigilance centre using the CDSCO ADR reporting form. |